Skip to main content
EFSA Journal logoLink to EFSA Journal
. 2007 Jul 16;5(7):515. doi: 10.2903/j.efsa.2007.515

Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) on the food colour Red 2G (E128) based on a request from the Commission related to the re‐evaluation of all permitted food additives

European Food Safety Authority (EFSA)
PMCID: PMC13129613  PMID: 42078057

The content is available as a PDF (194.4 KB).

EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food , 2007. Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) on the food colour Red 2G (E128) based on a request from the Commission related to the re‐evaluation of all permitted food additives. EFSA Journal 2007;5(7):515, 28 pp. doi: 10.2903/j.efsa.2007.515

Panel members: Fernando Aguilar, Herman Autrup, Susan Barlow, Laurence Castle, Riccardo Crebelli, Wolfgang Dekant, Karl‐Heinz Engel, Natalie Gontard, David Gott, Sandro Grilli, Rainer Gürtler, John Chr. Larsen, Jean‐Charles Leblanc, Catherine Leclercq, François Xavier Malcata, Wim Mennes, Maria Rosaria Milana, Iona Pratt, Ivonne Rietjens, Paul Tobback, Fidel Toldrá.

Acknowledgement: The Panel wishes to thank the members of the Additives working group: Fernando Aguilar, Dimitrios Boskou, David Gott, Sandro Grilli, Werner Grunow, Karolina Hulshof, John Chr. Larsen, Catherine Leclercq, Jean‐Charles Leblanc, Wim Mennes, Alicja Mortensen, Dominique Parent‐Massin, Annette Pöting, Iona Pratt, Ivonne Rietjens, Gerrit Speijers, Paul Tobback, Fidel Toldrá.

Adoption date: 5 July 2007

Published date: 16 July 2007

Question number: EFSA‐Q‐2007‐126

References

  1. BIBRA (1965). Acute and short‐term feeding studies on Red 2G with associated haematological investigations, British Industrial Biological Research Association, Research Report 3/1965. Unpublished report submitted to WHO (as referred to by JECFA, 1981).
  2. Bomhard, E. M. and Herbold, B. A. (2005). Genotoxic activities of aniline and its metabolites and their relationship to the carcinogenicity of aniline in the spleen of rats. Crit. Rev. Toxicol., 35, 783–835 [DOI] [PubMed] [Google Scholar]
  3. Cambridge, G. W. et al. (1980). Teratology study on Red 2G in the Colworth Wistar Rat. Unpublished report from Unilever Research Laboratories, submitted to WHO by Unilever Ltd. (as referred to by JECFA, 1981).
  4. ChemIDplus Advanced (via internet, 2006). Accessible via: chem.sis.nlm.nih.gov/chemidplus/
  5. CIIT (1982). 104‐Week Chronic Toxicity Study in Rats. Aniline Hydrochloride. Final Report. Hazleton Laboratories America Inc., Project No. 2010‐101, Virginia, USA. [Google Scholar]
  6. Codex Alimentarius (via internet, 2006). Accessible via: www.codexalimentarius.net/gsfaonline/index.html
  7. Daniel, J. W. (1962). The excretion and metabolism of edible colours. Tox. Appl. Pharmacol., 4, 572 (described in JECFA 1981 without reference; original study revisited). [DOI] [PubMed] [Google Scholar]
  8. EC (1994) Directive 94/36/EC of the European Parliament and the Council of 30 June 1994 on colours for use in foodstuffs.
  9. EC (1995) Commission Directive 95/45/EC of 26 July 1995 laying down specific purity criteria concerning colours for use in foodstuffs.
  10. Edwards, C. N. and Combes, R. D. (1983). Studies on the mutagenicity of commercial preparations of the food colour Red 2G after purification or oxidation. Mut. Res., 117, 127–134 (as referred to by TemaNord, 2002). [DOI] [PubMed] [Google Scholar]
  11. Edwards, C. N. and Combes, R. D. (1981). An evaluation of the Drosophila zeste somatic eye mutation test for the detection of genotoxic azo dyes and an aromatic amine. Mut. Res., 84, 221–226 (as referred to by TemaNord, 2002). [DOI] [PubMed] [Google Scholar]
  12. Edwards, C. N. and Combes, R. D. (1984). Mutagenicity studies of urine and faecal samples from rats treated orally with the food colourings Brown FK and Red 2G. Food Chem. Toxicol., 22, 593–597 (as referred to by TemaNord, 2002). [DOI] [PubMed] [Google Scholar]
  13. EPA . Report Doc #88‐890000051NTIS, 1988. (as referred to by TemaNord, 2002).
  14. EPA . Report Doc #89‐890000082NTIS, 1989. (as referred to by TemaNord, 2002).
  15. EU , 2004. European Chemicals Bureau. Institute for Health and Consumer Protection. European Union Risk Assessment Report on Aniline. Volume 50. [Google Scholar]
  16. Freifield, H. , Schilowa, A. and Ludwinowsky, R. (1937). Heinz bodies and methaemoglobin formation in poisoning by compounds containing amino and nitro groups. Folia Haematol., 56, 333–342 (as referred to by JECFA, 1981). [Google Scholar]
  17. Gellatly, J. B. M. and Burrough, R. (1966). Effects of diets containing aniline and metabolites of aniline on spleen weights; pathology. Unpublished report from Unilever Research Laboratories, submitted to WHO by Unilever Ltd (as referred to by JECFA, 1981).
  18. Gellatly, J. B. M. and Burrough, R. (1967). Pathology of Red 2G and phenylhydroxylamine in fat diets. Unpublished report from Unilever Research Laboratories, submitted to WHO by Unilever Ltd. (as referred to by JECFA, 1981).
  19. Gellatly, J. B. M. , Salmond, G. and Burrough, R. (1966). Sub‐acute toxicity of Red 2G; pathology. Unpublished report from Unilever Research Laboratories, submitted to WHO by Unilever Ltd. (as referred to by JECFA, 1981).
  20. Haveland‐Smith, R. B. , Combes, R. D. and Bridges, B. A. (1979). Methodology for the testing of food dyes for genotoxic activity: Experiments with Red 2G (C.I. 18050). Mut. Res., 64, 241–248 (as referred to by JECFA, 1981). [DOI] [PubMed] [Google Scholar]
  21. Haveland‐Smith, R. B. and Combes, R. D. (1980a). Screening of food dyes for genotoxic activity. Food Cosmet. Toxicol., 18, 215–221 (as referred to by JECFA, 1981). [DOI] [PubMed] [Google Scholar]
  22. Haveland‐Smith, R. B. and Combes, R. D. (1980b). Genotoxicity of the food colours Red 2G and Brown FK in bacterial systems. Use of structurally‐related dyes and azo‐reduction. Food Cosmet. Toxicol., 18, 223–228 (as referred to by JECFA, 1981). [DOI] [PubMed] [Google Scholar]
  23. Hughes, J. P. and Treon, J. F. (1954). Erythrocytic inclusion bodies in the blood of chemical workers. Arch. Hyg. occup. Med., 10, 192–202 (as referred to by JECFA, 1981). [PubMed] [Google Scholar]
  24. JECFA 25th report (1981a). FAO/WHO Joint Expert Committee on Food Additives. Toxicological evaluation of certain food additives. WHO Food Additives Series, No. 16.
  25. JECFA 25th report (1981b). FAO/WHO Joint Expert Committee on Food Additives. Evaluation of certain food additives. WHO Technical Report Series, No. 669.
  26. JECFA, 63rd meeting (2004) (via internet, 2006). Joint FAO/WHO Expert Committee on Food Additives. Aluminium Lakes of Colouring Matters, General Specifications. Accessible via: www.fao.org/ag/agn/jecfa‐additives/specs/Monograph1/Additive013.pdf
  27. Jenkins, F. P. and Campbell, P. J. (1966). Unpublished report from Unilever Research Laboratories, submitted to WHO by Unilever ltd. (as referred to by JECFA, 1981).
  28. Jenkins, F. P. et al. (1966a). Metabolism of Red 2G by rat liver homogenate. Unpublished report from Unilever Research Laboratories, submitted to WHO by Unilever Ltd. (as referred to by JECFA, 1981).
  29. Jenkins, F. P. (1966b). Metabolism of Red 2G (protein binding capacity). Unpublished report from Unilever Research Laboratories, submitted to WHO by Unilever Ltd. (as referred to by JECFA, 1981).
  30. Jenkins, F. P. at al. (1966c). Effects of diets containing aniline and metabolites of aniline on spleen weights. Unpublished report from Unilever Research Laboratories, submitted to WHO by Unilever Ltd. (as referred to by JECFA, 1981).
  31. Jenkins, F. P. et al. (1966d). Sub‐acute toxicity of Red 2G. Unpublished report from Unilever Research Laboratories, submitted to WHO by Unilever Ltd. (as referred to by JECFA, 1981).
  32. Jenkins, F. P. , Salmond, G. and Gellatly, J. B. M. (1966e). Sub‐acute toxicity of Red 2G in sausage meat. Unpublished report from Unilever Research Laboratories, submitted to WHO by Unilever Ltd. (as referred to by JECFA, 1981).
  33. Jenkins, F. P. et al. (1967). Effect of Red 2G and phenylhydroxylamine on spleen weight. Unpublished report from Unilever Research Laboratories, submitted to WHO by Unilever Ltd. (as referred to by JECFA, 1981).
  34. Jenkins, F. P. et al. (1972). The no‐effect dose of aniline in human subjects and a comparison of aniline toxicity in man and rat. Food Cosmet. Toxicol., 10, 671–679(as referred to by JECFA, 1981). [DOI] [PubMed] [Google Scholar]
  35. Jenkins, F. P. , Kennedy, S. and Williams, T. C. (1980). Erythropoiesis in the Colworth Wistar rat fed Red 2G. Unpublished report from Unilever Research Laboratories, submitted to WHO by Unilever Ltd. (as referred to by JECFA, 1981).
  36. Kiese, M. (1959). Significance of the oxidation of aniline to nitrosobenzene for the formation of methemoglobin after absorption of aniline into the organism. Arch. exp. Path. Pharmak., 235, 360–364 (as referred to by JECFA, 1981). [PubMed] [Google Scholar]
  37. NCI (1978). Bioassay of Aniline Hydrochloride for Possible Carcinogenicity. CAS No. 142‐04‐1. Technical Report Series No. 130, NTIS PB‐287539, National Cancer Institute; Bethesda, USA. [PubMed] [Google Scholar]
  38. Parke, D. V. (1960). Studies in detoxication 84. The metabolism of 14C aniline in the rabbit and other animals. Biochem. J., 77, 493–503 (as referred to by JECFA, 1981). [DOI] [PMC free article] [PubMed] [Google Scholar]
  39. Priestley, G. and O'Reilly, W. J. (1966). Protein binding and the secretion of some azo dyes in rat bile. J. Pharm. Pharmacol., 18, 41–45 (as referred to by JECFA, 1981). [DOI] [PubMed] [Google Scholar]
  40. Rodek, H. and Westhaus, H. (1952). Aniline poisoning in nurslings from ink and labeling dyes. Arch. Kinderh., 145, 77–90 (as referred to by JECFA, 1981). [PubMed] [Google Scholar]
  41. Rofe, P. (1957). Azo dyes and Heinz bodies. Brit. J. ind. Med., 14, 275–280 (as referred to by JECFA, 1981). [DOI] [PMC free article] [PubMed] [Google Scholar]
  42. Ryan, A. J. and Wright, S. E. (1961). The excretion of some azo dyes in rat bile. J. Pharm. Pharmacol., 13, 492–495 (as referred to by JECFA, 1981). [DOI] [PubMed] [Google Scholar]
  43. SCF (1975). Reports of the Scientific Committee for Food (1st series), opinion expressed 1974, p. 17, 19, 24. Accessible via : ec.europa.eu/food/fs/sc/scf/reports_en.html
  44. TemaNord (2002). Food additives in Europe 2000; Status of safety assessments of food additives presently permitted in the EU. TemaNord 2002:560. Accessible via: www.norden.org/pub/sk/showpub.asp?pubnr=2002:560
  45. Unilever (1974). Unpublished review of the biological effects of food colour Red 2G dated November 1974. Submitted to WHO by Unilever Ltd. (as referred to by JECFA, 1981).
  46. Walker, R. (1971). Personal communication to E. M. den Tonkelaar, National Institute of Public Health, Bilthoven, Netherlands: (as referred to by JECFA, 1981). [Google Scholar]
  47. EFSA (2005). Opinion of the Scientific Committee on a request from EFSA related to A Harmonised Approach for Risk Assessment of Substances which are both Genotoxic and Carcinogenic. (Request No EFSA‐Q‐2004‐020; adopted on 18 October 2005). (ADOPTED ON 18 OCTOBER 2005). The EFSA Journal, 282, 1–31. www.efsa.europa.eu/en/science/sc_commitee/sc_opinions/1201.html [Google Scholar]
  48. Filipsson, A.F. , Sand, S. , Nilsson, J , and Victorin, K. 2003. The benchmark dose method‐Review of available models, and recommendations for application in health risk assessment. Crit. Rev. Toxicol., 33(5), 505–542. [PubMed] [Google Scholar]

Articles from EFSA Journal are provided here courtesy of Wiley

RESOURCES